Psilocybin for depressio
- Conditions
- Major depressionMental and Behavioural DisordersDepression
- Registration Number
- ISRCTN14426797
- Lead Sponsor
- Imperial College London
- Brief Summary
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27210031 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29288686 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29387009 2020 results in https://pubmed.ncbi.nlm.nih.gov/31941394/ (added 12/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D)
2. No improvement despite two courses of antidepressant treatment for adequate duration (6 weeks minimum) within current episode
3. No magnetic resonance imaging (MRI) contraindications
1. Current or previously diagnosed psychotic disorder
2. Immediate family member with a diagnosed psychotic disorder
3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc)
4. History of suicide attempts
5. History of mania
6. Blood or needle phobia
7. Positive pregnancy test at screening or during the study
8. Current drug or alcohol dependence
9. Allergy to gelatine or lactose
10. Lack of appropriate use of contraception
11. Breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quick Inventory of Depressive Symptoms (QIDS) questionnaire at start of trial, then one day and one week post-psilocybin. QIDS is a self-report measure of depressive symptoms
- Secondary Outcome Measures
Name Time Method <br> 1. Beck Depression Inventory (BDI) questionnaire<br> 2. Hamilton Depression Rating Scale (HAM-D) questionnaire<br> 3. Montgomery–Åsberg Depression Rating Scale (MADRS) questionnaire<br>